A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 15
- 主要终点
- Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.
研究概览
简要总结
To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTPO in cancer patients with high risk of treatment-induced cardiac injury.
详细描述
This is an open-label prospective randomized multicenter study of rhTPO's prophylactic treatment of CTIT in patients receiving chemotherapy at high risk of cardiac injury. Adult cancer patients with high risk of cancer treatment-induced thrombocytopenia and cardiac injury were enrolled. Patients will be randomised into the rhTPO treatment group or non-rhTPO treatment group with a 2:1 ratio. The patients in rhTPO group will receive rhTPO 300U/kg/d subcutaneous injection for 5 days per cycle and total 3 cycles. The primary endpoint is to observe the improvement of platelet count by rhTPO during 3 cycles treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females greater than or equal to 18 years of age at signing of the informed consent.
- •Patients clinically judged to be at high risk of CTIT: Patients who had a platelet count below 50×10^9/L in the past 3 months; or patients who meet the criteria for prophylactic treatment in the Chinese Expert Consensus on the Management of Thrombocytopenia due to Oncology Chemotherapy (2018 Edition).The criteria for prophylactic treatment include: 1) The nadir platelet value in the last chemotherapy cycle was <50×10^9/L；Or 2)The patients with nadir platelet value ≥50×10^9/L and <75×10^9/L in the previous chemotherapy cycle also met at least one of the following risk factors for bleeding:
- •With a previous history of bleeding.
- •Chemotherapy regimens containing platinum, gemcitabine, cytarabine, anthracycline, etc.
- •Combination regimens containing targeted or chemotherapy drugs which regularly result in thrombocytopenia.
- •Thrombocytopenia caused by bone marrow infiltration of tumor cells.
- •Eastern Cooperative Oncology Group (ECOG) score ≥
- •Previous radiotherapy or ongoing radiotherapy, especially for long and flat bones (e.g. pelvis, sternum, etc.).
- •Platelet count ≥75×10^9/L and <150×10^9/L, Hemoglobin ≥9.0 g/dL and absolute neutrophils ≥1.5×10^9 /L during screening.
- •Patients with medium and high-risk with cardiotoxicity risk score (CRS) ≥3 and ECOG score of 0, 1, or 2 during screening.
- •The current tumor treatment belongs to the scope of neoadjuvant, adjuvant, relapsed metastatic/advanced first-line and second-line therapies, anticipated to receive at least 2 cycles of current regimen with survival ≥ 6 months. The regimens may be 14-day, 21-day or 28-day cycles combined with targeted, immunotherapy, etc.
- •Inclusion of organ tumours and lymphomas, with no restriction on the type and stage of organ tumours, etc.
- •Patient provided signed informed consent
排除标准
- •Patients with severe cerebrovascular disease (including but not limited to stroke, cerebrovascular accident, etc.) or serious heart disease (such as heart valve disease, arrhythmia, myocardial infarction, congenital heart disease, cardiomyopathy, heart failure, etc.) within the 3 months.
- •Previous thrombocytopenia caused by non-oncology chemotherapy drugs within 6 months, including but not limited to primary immune thrombocytopenia, EDTA-dependent pseudo-thrombocytopenia, hypersplenism, etc.
- •Patients with blood dysplasia-related diseases such as aplastic anemia, myeloproliferative diseases, multiple myeloma, myelodysplastic syndromes, etc.
- •Patients with any arterial and venous thrombotic events within the past 6 months；
- •Patients who had agents that increase platelet production or transfusion of platelets within the past 1 month.
- •Abnormal liver function:
- •Patients without liver metastasis: ALT/AST > 3ULN (upper limit of normal value) and TBIL > 3ULN.
- •Patients with liver metastasis: ALT/AST≥5ULN, TBIL≥5ULN.
- •Abnormal renal function: Scr≥1.5ULN or eGFR≤60ml/min.
- •Patients with uncontrolled serious infection;
- •Pregnant women or those planning to have children during the study period and breastfeeding patients.
- •Any condition that the investigator considers inappropriate for inclusion in this study.
研究组 & 干预措施
rhTPO
The study in a 2:1 randomization ratio (110 subjects to rhTPO).
干预措施: rhTPO (Drug)
Control
The study in a 2:1 randomization ratio (55 subjects to control group).
干预措施: Control (Drug)
结局指标
主要结局
Proportion of patients whose platelet count is ≥ 75×10^9/L after 2 cycles cancer treatment.
时间窗: After 2 cycles cancer treatment (month 1.5~month 2, depends on chemotherapy regimen), each cycle is 14, 21 or 28 days
Efficacy was defined as treatment without salvage therapy to increase platelet counts.
次要结局
- Proportion of patients receiving salvage treatment to increase platelet counts.(during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days))
- Changes in cTnT/cTnI(1 and 3 months after initial treatment)
- Changes in NT-proBNP(1 and 3 months after initial treatment)
- Changes in LVEF(1 and 3 months after initial treatment)
- Changes in neutrophile granulocyte count(during 3 cycles cancer treatment period(each cycle is 14, 21 or 28 days))
- Incidence of adverse events(from study start date to the end of follow-up, up to 3 months)
研究者
Xia Yunlong
Director
The First Affiliated Hospital of Dalian Medical University